MM drug Revlimid continues to thrive after patent expiry

the 'backbone treatment' for multiple myeloma

Continues to lead the market despite entry of generics

Has expanded indications to 7 in 4 disease areas

Sales of the multiple myeloma drug Revlimid continue to thrive even after patent expiry in Korea.

 

According to industry sources, Bristol Myers Squibb Korea’s Revlimid (lenalidomide) still boasts its originality with an 80% market share.

 

As of Q3 2024 (IQVIA), Revelimid's sales were KRW 11.2 billion, significantly outpacing the sales of generics such as Lenaloma (KRW 800 million), Lenalid (KRW 981.1 million), Leblikin (KRW 305.85 million), and Lenaldo (KRW 35.51 million) during the same period.

 

Revlimid has been used for various blood diseases for nearly 20 years since its approval by the U.S.

 

Food and Drug Administration (FDA) in 2005 and has solidified its position as the “forefather” in the blood cancer treatment space.

 

In particular, it has become the backbone in the multiple myeloma treatment space, being used in combination with newer therapies.

 

Since its launch in 2009, it has been expanded to gain approval for 7 indications in four diseases, including multiple myeloma, and has been used in various combinations regardless of transplantation history or lines of treatment.

 

In the recently updated National Comprehensive Cancer Network (NCCN) guidelines, combination therapies that include Revlimid are now recommended as Category 1 Preferred regimens, demonstrating the solid foundation it has built over the past 20 years.

 

In clinical practice, Revlimid is actively used in combination with various therapies as a first-line treatment for multiple myeloma in Korea and abroad.

 

Since April 2022, RVd therapy has been reimbursed by insurance in Korea, enabling newly diagnosed patients with multiple myeloma to receive REVLIMID regardless of whether or not they receive an autologous stem cell transplant.

 

In addition to the first-line treatment, the relapsing nature of multiple myeloma makes it critical to maintain a favorable post-transplant prognosis with maintenance therapy, and starting in January 2023, Revlimid maintenance therapy was reimbursed and is available as a treatment option that focuses on improving survival in patients who achieve a stable disease response or better following autologous stem cell transplant.

 

In a meta-analysis of three randomized controlled trials of Revlimid (CALGB 100104, IFM 2005-02, GIMEMA RV-MM-PI-209) conducted on 1,208 patients (605 in the lenalidomide maintenance arm and 603 in the placebo or observation arm), the PFS (progression-free survival) of patients that used Revlimid maintenance as monotherapy was 52.8 months, which was an over twofold improvement from the 23.5 months observed in the control arm, reducing the risk of relapse and death by 52%.

 

At a median follow-up of 79.5 months, median overall survival (OS) in the Revlimid maintenance arm was not reached, compared to 86.0 months in the placebo or observation arm.

 

At a median follow-up of 88.8 months, median overall survival (mOS) in the maintenance arm was 111 months, an increase of 25 months compared to 86.9 months in the placebo or observation arm, and the risk of death was significantly reduced by 23% compared to placebo or observation arm.

 

Revlimid maintenance therapy is recommended at the highest level in both the NCCN and European Society for Medical Oncology (ESMO) guidelines.

 

Hyeon Seok Eom, Professor of Hematology/Oncology at the National Cancer Center said, “Revlimid has been used for many years in multiple myeloma patients at various stages of treatment, from first-line to maintenance therapy,” said Dr.

 

Hyunseok Eom, Professor of Hematology/Oncology at the National Cancer Center.

 

As it has consistently provided multiple treatment options for patients with multiple myeloma in Korea and abroad, we expect it to bring positive synergies with the new drugs under development.”